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All stakeholders, including citizens, NGOs, etc. have an important role in the law making process. But for many stakeholders, the process is not obvious or easily explained. In PRS, we often receive a number of requests from NGOs about how it is that they can get Parliament to make changes in legislation and what would be productive ways in which citizens can make a difference in the law making process. To address this, PRS has developed a short Primer on "Engaging with Policy Makers: Ideas on Contributing to the Law Making Process", in which we have tried to explain the process of how a Bill becomes an Act and some of the opportunities for citizen groups to become part of the process. Sometimes, large parts of a Bill that is introduced in Parliament may not be agreeable to some groups. In such cases there is a tendency among NGOs to sometimes decide to redraft the Bill. To the extent that NGOs think of redrafting a Bill as a tactical negotiating position, they may have a point in trying to redraft legislation. To the extent that NGOs think of such redrafting as a way to keep the discourse alive on the most important issues in any legislation, such efforts are welcome and useful. But if there is a belief that the Bill introduced in Parliiament will be withdrawn to introduce another Bill on the same subject as drafted by NGOs, then history suggests that the probability of that happening is close to zero. This is not a comment on the quality of the Bill that may be drafted by the group of NGOs, but rather a result of a complex set of issues about lawmaking in India. Despite the odds, there are some recent examples in which NGOs were able to bring about significant changes to Bills in Parliament. The Right to Information Act stands out as one of the best examples in recent times. On the recently passed Right to Education Bill, NGOs were able to exert sufficient pressure to bring about changes in the Bill, and also get the government to bring in an amendment Bill to make further changes. In the Seeds Bill which was introduced in 2004, the Government appears to have agreed to bring about important changes thanks to the efforts of a number of farmer groups approaching the government directly, and through their local MPs and political parties. It would be useful if we can get more examples/ comments/ suggestions about how some NGOs were able to bring about these changes in Bills. This will help more people understand how their voices can be heard in the corridors of power.
The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO). CDSCO is the agency mandated with the regulation of drugs and cosmetics in India. The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation. The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO. It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules]. The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import. State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:
The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy. These trials are necessary for both domestically manufactured and imported drugs. However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws. Following are some of the Report’s findings:
